SPINAL CORD AND IMPLANTABLE PERIPHERAL NERVE STIMULATORS Version 18.0; Effective

Transcription

1 evicore healthcare. Clinical Decision Support Tool Diagnostic Strategies This tool addresses common symptoms and symptom complexes. Imaging requests for patients with atypical symptoms or clinical presentations that are not specifically addressed will require physician review. Consultation with the referring physician, specialist and/or patient s Primary Care Physician (PCP) may provide additional insight. SPINAL CORD AND IMPLANTABLE PERIPHERAL NERVE STIMULATORS Version 18.0; Effective This version incorporates accepted revisions prior to 12/31/15 CPT (Current Procedural Terminology) is a registered trademark of the American Medical Association (AMA). CPT five digit codes, nomenclature and other data are copyright 2016 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values or related listings are included in the CPT book. AMA does not directly or indirectly practice medicine or dispense medical services. AMA assumes no liability for the data contained herein or not contained herein. Page 1 of 12

2 CMM-211- Spinal Cord Stimulators CMM-211 Spinal Cord Stimulators Definitions Indications and Non-Indications Procedure ( CPT ) Codes References 9 Page 2 of 12

3 CMM Definitions CMM-211~Spinal Cord Stimulators Spinal cord stimulation, also known as dorsal column stimulation, is a reversible therapy applied for neuropathic pain with techniques that include multi-output implanted pulse generators and a choice of electrodes, some of which can be placed percutaneously. The technical goal of this therapy is to achieve stimulation of paresthesia of the dorsal horn of the spinal cord at a subjectively comfortable level, overlapping an individual s topography of pain. The procedure initially involves a short-term, trial (e. g., three to seven [3-7] days) of percutaneous (temporary) spinal cord stimulation, prior to the subcutaneous (permanent) implantation of the spinal cord stimulation device, to determine whether the spinal cord stimulator device will induce sufficient pain relief to render it medically necessary. In contrast to spinal cord stimulation, peripheral nerve stimulation involves implantation of electrodes near or on a peripheral nerve to reduce pain. Peripheral nerve field stimulation is a technology that involves placement of electrodes subcutaneously within an area of maximal pain, with the objective of stimulating a region of affected nerves to reduce pain. Depending on the targeted nerve, leads may be placed percutaneously just under the skin or via an open approach for larger deeper peripheral nerves. Similar to spinal cord stimulation, a short term trial is required prior to permanent implantation of a generator. The use of these technologies, used alone or in combination with spinal cord stimulation for treatment of pain conditions is under investigation. CMM Indications and Non-Indications The determination of medical necessity for implantation of a dorsal spinal cord stimulator is always made on a case-by-case basis. Dorsal Column Spinal Cord Stimulator A dorsal column spinal cord stimulator (SCS) is considered medically necessary for any of the indications listed below when the associated criteria are met: A short-term trial (e.g., three to seven [3 7] days) of a dorsal column spinal cord stimulator (SCS) is considered medically necessary for the treatment of chronic, intractable pain secondary to EITHER of the following indications: Failed back syndrome (FBS) with intractable neuropathic leg pain Complex regional pain syndrome (CRPS)/reflex sympathetic dystrophy (RSD) Page 3 of 12

4 And when ALL of the following criteria are met: Failure of at least six consecutive months of physician-supervised conservative medical management (e.g., pharmacotherapy, physical therapy, cognitive therapy, and activity lifestyle modification) Surgical intervention is not indicated An evaluation by a mental health provider (e.g., a face-to-face assessment with or without psychological questionnaires and/or psychological testing) reveals no evidence of an inadequately controlled mental health problem (e.g., alcohol or drug dependence, depression, psychosis) that would negatively impact the success of a SCS or contraindicate its placement. Permanent implantation of a dorsal column spinal cord stimulator (SCS) is considered medically necessary for the treatment of chronic, intractable pain secondary to EITHER of the following indications: Failed back syndrome (FBS) with intractable neuropathic leg pain Complex regional pain syndrome (CRPS)/reflex sympathetic dystrophy (RSD) And when ALL of the following criteria are met: Failure of at least six consecutive months of physician-supervised conservative medical management (e.g., pharmacotherapy, physical therapy, cognitive therapy, activity lifestyle modification) Surgical intervention is not indicated An evaluation by a mental health provider (e.g., a face-to-face assessment with or without psychological questionnaires and/or psychological testing) reveals no evidence of an inadequately controlled mental health problem (e.g., alcohol or drug dependence, depression, psychosis) that would negatively impact the success of a SCS or contraindicate its placement At least a 50% reduction in pain has been demonstrated during a short-term trial of SCS. Chronic Critical Limb Ischemia (CLI) A short-term trial (e.g., three to seven [3 7] days) of a dorsal column spinal cord stimulator (SCS) is considered medically necessary for the treatment of chronic, intractable pain secondary to chronic critical limb ischemia (CLI) when BOTH of the following criteria are met: Failure of available conventional multidisciplinary medical (e.g., pharmacological, physical therapy) and surgical management (e.g., revascularization) Page 4 of 12

5 An evaluation by a mental health provider (e.g., a face-to-face assessment with or without psychological questionnaires and/or psychological testing) reveals no evidence of an inadequately controlled mental health problem (e.g., alcohol or drug dependence, depression, psychosis) that would negatively impact the success of a SCS or contraindicate its placement. Permanent implantation of a dorsal column spinal cord stimulator (SCS) is considered medically necessary for the treatment of chronic, intractable pain secondary to chronic critical limb ischemia (CLI) when all of the following criteria are met: Failure of available conventional multidisciplinary medical (e.g., pharmacological, physical therapy) and surgical management (e.g., revascularization) An evaluation by a mental health provider (e.g., a face-to-face assessment with or without psychological questionnaires and/or psychological testing) reveals no evidence of an inadequately controlled mental health problem (e.g., alcohol or drug dependence, depression, psychosis) that would negatively impact the success of a SCS or contraindicate its placement Beneficial clinical response from a temporarily implanted electrode has been demonstrated prior to consideration of permanent implantation. Chronic Stable Angina Pectoris A short-term trial (e.g., three to seven [3 7] days) of a dorsal column spinal cord stimulator (SCS) is considered medically necessary for the treatment of chronic, intractable pain secondary to chronic stable angina pectoris as medically necessary for myocardial ischemia when all of the following criteria are met: angina pectoris is Canadian Cardiovascular Society (CCS) functional class III or class IV (see Appendix A) individual has documented significant coronary artery disease (CAD) and is not a suitable candidate for a revascularization procedure optimal pharmacological treatment using anti-anginal medications (e.g., long-acting nitrates, beta-adrenergic blockers, or calcium-channel antagonists) has failed to adequately improve anginal symptoms an evaluation by a mental health provider (e.g., a face-to-face assessment with or without psychological questionnaires and/or psychological testing) reveals no evidence of an inadequately controlled mental health problem (e.g., alcohol or drug dependence, depression, psychosis) that would negatively impact the success of a SCS or contraindicate its placement. Permanent implantation of a dorsal column spinal cord stimulator (SCS) is considered medically necessary for the treatment of chronic, intractable pain secondary to chronic Page 5 of 12

6 stable angina pectoris as medically necessary for myocardial ischemia when all of the following criteria are met: Angina pectoris is Canadian Cardiovascular Society (CCS) functional class III or class IV (see Appendix A) The individual has documented significant coronary artery disease (CAD) and is not a suitable candidate for a revascularization procedure Optimal pharmacological treatment using anti-angina medications (e.g., long-acting nitrates, beta-adrenergic blockers, or calcium-channel antagonists) has failed to adequately improve anginal symptoms An evaluation by a mental health provider (e.g., a face-to-face assessment with or without psychological questionnaires and/or psychological testing) reveals no evidence of an inadequately controlled mental health problem (e.g., alcohol or drug dependence, depression, psychosis) that would negatively impact the success of a SCS or contraindicate its placement Beneficial clinical response from a temporarily implanted electrode has been demonstrated prior to consideration of permanent implantation. Dorsal Column Spinal Cord Stimulator Replacement The replacement of a malfunctioning dorsal column spinal cord stimulator (SCS) and/or battery/generator is considered medically necessary for an individual who meets ALL of the above criteria and the existing stimulator and/or battery/generator replacement are/is no longer under warranty. Dorsal Column Spinal Cord Stimulator Not Covered Services A dorsal column spinal cord stimulator (SCS) is considered experimental, investigational or unproven for any other indication including but not limited to: o Post-amputation pain (phantom limb pain) o Post-herpetic neuralgia o Peripheral neuropathy o Dysesthesias involving the lower extremities secondary to spinal cord injury. Peripheral Nerve Stimulation Peripheral nerve stimulation, including peripheral nerve field stimulation, is considered experimental, investigational, or unproven for treatment of acute or chronic pain conditions, including ANY of the following: o Failed back syndrome (FBS) with intractable neuropathic leg pain o Complex regional pain syndrome (CRPS)/reflex sympathetic dystrophy (RSD) o Chronic Critical Limb Ischemia (CLI) Page 6 of 12

7 o Chronic Stable Angina Pectoris o Post-amputation pain (phantom limb pain) o Post-herpetic neuralgia o Peripheral neuropathy o Dysesthesias involving the lower extremities secondary to spinal cord injury. High Frequency Spinal Cord Stimulation for Chronic Pain Implantation of a high frequency spinal cord stimulator for treatment of chronic pain is considered experimental, investigational or unproven. Appendix A New York Heart Association and Canadian Cardiovascular Society Functional Classifications Class I II III IV New York Heart Association Functional Classification Patients with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain. Patient with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased. Canadian Cardiovascular Society Functional Classification Ordinary physical activity does not cause angina, such as walking and climbing stairs. Angina occurs with strenuous or rapid or prolonged exertion at work or recreation. Slight limitation of ordinary activity. Walking or climbing stairs rapidly, walking uphill, walking or stair climbing after meals, in cold, in wind, or under emotional stress, or only during the few hours after awakening. Walking more than two blocks on the level and climbing more than one flight of ordinary stairs at a normal pace and in normal conditions. Marked limitation of ordinary physical activity. Walking one to two blocks on the level and climbing one flight in normal conditions and at a normal pace. Inability to carry on any physical activity without discomfort anginal syndrome may be present at rest. (Heart Failure Society of America [HFSA], 2006; Gibbons, et al., 2002; American Heart Association [AHA], 1994; Canadian Cardiovascular Society [CCS], 1976). Page 7 of 12

8 CMM Procedure (CPT ) Codes This guideline relates to the CPT code set below. Codes are displayed for informational purposes only. Any given code s inclusion on this list does not necessarily indicate prior authorization is required. CPT Code Description/Definition Percutaneous implantation of neurostimulator electrode array, epidural Laminectomy for implantation of neurostimulator electrodes, plate/paddle, epidural Removal of spinal neurostimulator electrode percutaneous array(s), including fluoroscopy, when performed Removal of spinal neurostimulator electrode plate/paddle(s) placed via laminotomy or laminectomy, including fluoroscopy, when performed Revision including replacement, when performed, of spinal neurostimulator electrode percutaneous array(s), including fluoroscopy, when performed Revision including replacement, when performed, of spinal neurostimulator electrode plate/paddle(s) place via laminectomy, including fluoroscopy, when performed Insertion or replacement of spinal neurostimulator pulse generator or receiver, direct or inductive coupling Revision or removal of implanted spinal neurostimulator pulse generator or receiver Electronic analysis of implanted neurostimulator pulse generator system (e.g., rate, pulse, amplitude and duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); simple or complex brain, spinal cord, or peripheral (i.e., cranial nerve, peripheral nerve, autonomic nerve, neuromuscular) neurostimulator pulse generator/transmitter, without reprogramming Electronic analysis of implanted neurostimulator pulse generator system (e.g., rate, amplitude and duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurement(s); simple spinal cord, or peripheral (i.e., peripheral nerve, automatic nerve, neuromuscular) neurostimulator pulse generation/transmitter, with intraoperative or subsequent programming Electrode analysis of implanted neurostimulator pulse generator system (e.g., rate, pulse amplitude and duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurement(s); complex spinal cord, or peripheral (except cranial nerve) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming This list may not be all inclusive and is not intended to be used for coding/billing purposes. The final determination of reimbursement for services is the decision of the health plan and is based on the individual s policy or benefit entitlement structure as well as claims processing rules. Page 8 of 12

9 CMM 211.4: References 1. Amann W, Berg P, Gersbach P, et al; European Peripheral Vascular Disease Outcome Study SCS- EPOS. Spinal cord stimulation in the treatment of non-reconstructable stable critical leg ischaemia: results of the European Peripheral Vascular Disease Outcome Study (SCS-EPOS). Eur J Vasc Endovasc Surg. 2003;26(3): American College of Occupational and Environmental Medicine. Occupational Medicine Practice Guideline, 2nd Ed American Medical Association. Current Procedural Terminology 2014 Professional Edition. 4. Burns B, Watkins L, Goadsby PJ. Treatment of intractable chronic cluster headache by occipital nerve stimulation in 14 patients. Neurology 2009; 72: Burns B, Watkins L, Goadsby PJ. Treatment of hemicrania continua by occipital nerve stimulation with a bion device: long---term follow---up of a crossover study. Lancet Neurol 2008;7: Claeys L, Berg W, Jonas S. Spinal cord stimulation in the treatment of chronic critical limb ischemia. Acta Neurochir Suppl. 2007;97(Pt 1): Cruccu G, Aziz T, Garcia-Larrea L, et al. EFNS guidelines on neurostimulation therapy for neuropathic pain. Eur J Neurol. 2007;14(9): Daousi C, Benbow SJ, MacFarlane IA. Electrical spinal cord stimulation in the long---term treatment of chronic painful diabetic neuropathy. Diabet Med 2005;22: de Vos CC, Meier K, Zaalberg PB, et al. Spinal cord stimulation in patients with painful diabetic neuropathy: a multicenter randomized clinical trial. Pain 2014;155: Fontaine D, Christophe Sol J, Raoul S, Fabre N, Geraud G, Magne C et al. Treatment of refractory chronic cluster headache by chronic occipital nerve stimulation. Cephalalgia 2011;31: Forouzanfar T, Kemler M, Weber W, et al. Spinal cord stimulation in complex regional pain syndrome: cervical and lumbar devices are comparably effective. Br J Anaesth. 2004;92(3): Gersbach P, Argitis V, Gardaz Jpet al. Late outcome of spinal cord stimulation for unreconstructable and limb-threatening lower limb ischemia. Eur J Vasc Endovasc Surg. 2007;33(6): Harke H, Gretenkort P, Ladleif H, Rahman S. Spinal cord stimulation in sympathetically maintained complex regional pain syndrome type I with severe disability. A prospective clinical study. Eur J Pain. 2005;9(4): Jivegård L, Augustinsson L, Holm J, et al. Effects of spinal cord stimulation (SCS) in patients with inoperable severe lower limb ischaemia: a prospective randomised controlled study. Eur J Vasc Endovasc Surg. 1995;9(4): Kapural L, Narouze S, Janicki TI, Mekhail N. Spinal cord stimulation is an effective treatment for the chronic intractable visceral pelvic pain. Pain Med. 2006;;7(5): Kemler M, Barendse GA van Kleef M, et al. Spinal cord stimulation in patients with chronic reflex sympathetic dystrophy. N Engl J Med. 2000;343(9): Kemler M, de Vet H, Barendse G, et al. Effect of spinal cord stimulation for chronic complex regional pain syndrome Type I: five-year final follow-up of patients in a randomized controlled trial. J Neurosurg. 2008;108(2): Kemler M, de Vet H, Barendse G, et al. Spinal cord stimulation for chronic reflex sympathetic dystrophy five year follow-up. N Engl J Med. 2006;354(22): Kemler M, de Vet H, Barendse G, et al. The effect of spinal cord stimulation in patients with chronic reflex sympathetic dystrophy: two years follow-up of the randomized controlled trial. Ann Neurol. 2004;55: Page 9 of 12

10 20. Kemler M, Furnee C. Economic evaluation of spinal cord stimulation for chronic reflex sympathetic dystrophy. Neurology. 2002;59(8): Klomp H, Spinc le G, Steyerberg E, et al. Spinal-cord stimulation in critical limb ischaemia: a randomised trial. ESES Study Group. Lancet. 1999;353(9158): Kumar K, Hunter G, Demeria D. Spinal cord stimulation in treatment of chronic benign pain: challenges in treatment planning and present status, a 22-year experience. Neurosurgery. 2006;58(3): ; discussion Latif O, Nedeljkovic S, Stevenson L. Spinal cord stimulation for chronic intractable angina pectoris: a unified theory on its mechanism. Clin Cardiol. 2001;24: Magis D, Allena M, Bolla M, De Pasqua V, Remacle JM, Schoenen J. Occipital nerve stimulation for drug---resistant chronic cluster headache: a prospective pilot study. Lancet Neurol 2007; 6: Magis D, Gerardy PY, Remacle JM, Schoenen J. Sustained effectiveness of occipital nerve stimulation in drug---resistant chronic cluster headache. Headache 2011;51: Magis D, Schoenen J. Advances and challenges in neurostimulation for headaches. Lancet Neurol 2012;11: Lipton R, Goadsby P, Cady R, Aurora SK, Grosberg B, Freitag F et al. PRISM study: occipital nerve stimulation for treatment---refractory migraine. Cephalalgia 2009;29: Mailis-Gagnon A, Furlan A, Sandoval J, Taylor R, Spinal cord stimulation for chronic pain, 29. Cochrane Database Syst Rev. 2004;3:CD Mannheimer C, Eliasson T, Augustinsson LE, et al. Electrical stimulation versus coronary artery bypass surgery in severe angina pectoris: the ESBY study. Circulation. 1998;97: Marin JC, Goadsby P. Response of SUNCT (short---lasting unilateral neuralgiform headaches with conjunctival injection and tearing), SUNA (short---lasting unilateral neuralgifom headaches with autonomic symptoms) and primary stabbing headaches to occipital nerve stimulation (ONS). Neurology 2010;74:P04.006, abstract. 32. McGreevy K, Williams K. Contemporary insights into painful diabetic neuropathy and treatment with spinal cord stimulation. Curr Pain Headache Rep 2012;16: National Institute for Health and Care Excellence (NICE). Pain (chronic neuropathic or ischaemic) - spinal cord stimulation: final appraisal determination. September North R, Calkins S, Campbell D, et al. Automated, patient-interactive, spinal cord stimulator adjustment: a randomized controlled trial. Neurosurgery. 2003;52(3): North R, Kidd D, Farrokhi F, Piantadosi S. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain: a randomized, controlled trial. Neurosurgery. 2005;56(1): North R, Kidd D, Lee M, et al. A prospective, randomized study of spinal cord stimulation versus reoperation for failed back surgery syndrome: initial results. Stereotact Funct Neurosurg. 1994;62: North R, Kidd H, Piantadosi S. Spinal cord stimulation versus reoperation for failed back surgery syndrome: a prospective, randomized study design. Acta Neurochir. 1995;64(Suppl): North R, Kidd D, Shipley J, Taylor R. Spinal cord stimulation versus reoperation for failed back surgery syndrome: a cost effectiveness and cost utility analysis based on a randomized, controlled trial. Neurosurgery. 2007;61(2): Pedrini L, Magnoni F. Spinal cord stimulation for lower limb ischemic pain treatment. Interact Cardiovasc Thorac Surg. 2007;6(4): Reed K. Peripheral neuromodulation and headaches: history, clinical approach, and considerations Page 10 of 12

11 on underlying mechanisms. Curr pain Headache Rep 2013;17: Reed KL, Black SB, Banta CJ 2nd, Will KR. Combined occipital and supraorbital neurostimulation for the treatment of chronic migraine headaches: initial experience. Cephalalgia 2010;30: Saper JR, Dodick DW, Silberstein SD, McCarville S, Sun M, Goadsby PJ. Occipital nerve stimulation for the treatment of intractable chronic migraine headache: ONSTIM feasibility study. Cephalalgia 2011; 31: Schwedt TJ, Dodick DW, Trentman TL, Zimmerman RS. Response to occipital nerve block is not useful in predicting efficacy of occipital nerve stimulation. Cephalalgia 2007; 27: Shanahan P, Watkins L, Matharu M. Treatment of medically intractable short--- lasting unilateral neuralgiform headache attacks with conjunctival injection and tearing (SUNCT) and short---lasting unilateral neuralgiform headache attacks with autonomic symptoms (SUNA) with occipital nerve stimulation (ONS) in 6 patients. Cephalalgia 2009;29: Silberstein S, Dodick D, Saper J, Huh B, Slavin KV, Sharan A et al. Safety and efficacy of peripheral nerve stimulation of the occipital nerves for the management of chronic migraine: Results from a randomized, multicenter, double---blinded, controlled study. Cephalalgia 2012;32(16): Skaribas I, Calvillo O, Delikanaki---Skaribas E. Occipital peripheral nerve stimulation in the management of chronic intractable occipital neuralgia in a patient with neurofibromatosis type 1: a case report. Journal of Medical Case Reports 2011;5:174.Lambru G, Matharu M. Occipital nerve stimulation in primary headache syndromes. Ther Adv Neurol Disord 2012;5(1): Slangen R, Pluijms WA, Faber CG, Dirksen CD, Kessels AG, van Kleef M. Sustained effect of spinal cord stimulation on pain and quality of life in painful diabetic peripheral neuropathy. Br J Anaesth 2013;111: Slangen R, Schaper NC, Faber CG, et al. Spinal cord stimulation and pain relief in painful diabetic peripheral neuropathy: a prospective two---center randomized controlled trial. Diabetes Care 2014;37: Stancák A, Kozák J, Vrba I, et al. Functional magnetic resonance imaging of cerebral activation during spinal cord stimulation in failed back surgery syndrome patients. Eur J Pain. 2008;12(2): Stanton-Hicks M, Burton A, Bruehl S, et al. An updated interdisciplinary clinical pathway for CRPS: report of an expert panel. Pain Pract. 2005; 84(3):S4-S Sundaraj S, Johnstone C, Noore F, et al. Spinal cord stimulation: a seven-year audit. J Clin Neurosci Apr;12(3): Taylor R, Buyten J, Buchser E. Spinal cord stimulation for complex regional pain syndrome: A systematic review of the clinical and cost-effectiveness literature and assessment of prognostic factors. Eur J Pain. 2006;10(2): Taylor R, Taylor R. Spinal cord stimulation for failed back surgery syndrome: a decision-analytic model and cost-effectiveness analysis. Int J Technol Assess Health Care. 2005;21(3): TenVaarwerk I, Jessurun G, DeJongste M, et al. Clinical outcome of patients treated with spinal cord stimulation for therapeutically refractory angina pectoris. The Working Group on Neurocardiology. Heart. 1999;82(1): Tesfaye S, Watt J, Benbow S, et al. Electrical spinal-cord stimulation for painful diabetic peripheral neuropathy. Lancet. 1996;348: Ubbink D, Vermeulen H. Spinal cord stimulation for critical leg ischemia: a review of effectiveness and optimal patient selection. J Pain Symptom Manage. 2006;31:S30-S Ubbink D, Vermeulen H. Spinal cord stimulation for non-reconstructable chronic critical leg ischaemia. Cochrane Database Syst Rev. 2005;CD Page 11 of 12

12 59. van Beek M, Slangen R, Schaper N, Faber C, Joosten E, Dirksen C, van Dongen R, Kessels A, van Kleef M. Sustained treatment effect of spinal cord stimulation in painful diabetic peripheral neuropathy: 24---month follow---up of a prospective two---center randomized controlled trial. Diabetes Care 2015;38:e132---e Weiner RL, Reed KL (1999) Peripheral neurostimulation for control of intractable occipital neuralgia. Neuromodulation 2: Workloss Data Institute. Official Disability Guidelines Page 12 of 12